Beyond the ordinary

This is where our journey begins. Get to know our business and what we do, and how we're committed to quality and great service. Join us as we grow and succeed together. We're glad you're here to be a part of our story.

Services

 

  • QPPV & PSMF Services: Provision of EU/Deputy QPPV & LPPV, along with comprehensive creation and maintenance of the Pharmacovigilance System Master File (PSMF).
  • Case Processing & E2B Reporting: Full-cycle ICSR handling, validation, MedDRA coding, and expedited regulatory submissions.
  • Medical Literature Screening: Strict local (EOF-regulated) and global scientific literature monitoring and MLM management.
  • Aggregate Reporting & Safety Signals: Expert authoring of PSURs, DSURs, Risk Management Plans (RMP), and continuous benefit-risk evaluations.
  • Tailomade projects according to the customer's needs.

 

Business

Expert Oversight, Tailored for Your Growth

Managed directly by Panos K. Katsaris, Pharmacist, MBA, an Eudravigilance-certified Pharmacovigilance expert with over 15 years of institutional experience as an EU QPPV and Local Safety Officer for global pharma leaders (Teva, Actavis, Watson, Genepharm).

Why Mid-Sized Pharma Partners with Us:

  • Direct Expert Access: No junior accounts or offshore call centers. You deal directly with a veteran Pharm.D.
  • Agility & Flexibility: Fully customized SOPs and
  • workflows tailored strictly to your company’s size and target markets.
  • Cost Optimization: Minimal operational overhead allows us to deliver premier regulatory compliance up to 40% more cost-effectively than global mega-CROs.

Beyond the ordinary

This is where our journey begins. Get to know our business and what we do, and how we're committed to quality and great service. Join us as we grow and succeed together. We're glad you're here to be a part of our story.

Professional services

We offer a range of specialized services tailored to meet your individual needs. Our approach is focused on understanding and responding to what you require, providing effective and practical solutions.

What we do

We offer a range of specialized services tailored to meet your individual needs. Our approach is focused on understanding and responding to what you require, providing effective and practical solutions.

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